WO2017123764A1 - Dispositif modulaire à sonde de mesure du sang intravasculaire par fibre optique périphérique et procédé associé - Google Patents

Dispositif modulaire à sonde de mesure du sang intravasculaire par fibre optique périphérique et procédé associé Download PDF

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Publication number
WO2017123764A1
WO2017123764A1 PCT/US2017/013199 US2017013199W WO2017123764A1 WO 2017123764 A1 WO2017123764 A1 WO 2017123764A1 US 2017013199 W US2017013199 W US 2017013199W WO 2017123764 A1 WO2017123764 A1 WO 2017123764A1
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WIPO (PCT)
Prior art keywords
catheter
arterial
fiber optic
fiber
probe
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PCT/US2017/013199
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English (en)
Inventor
Robert J. Anderson
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Bloodworks, Llc
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Publication of WO2017123764A1 publication Critical patent/WO2017123764A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14556—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases by fluorescence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
    • A61B2562/223—Optical cables therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes

Definitions

  • Oxygen saturation is the measure of oxygen attached to hemoglobin and carried in the blood; this is otherwise referred to as oxyhemoglobin saturation. Oxygen saturation can be used by medical professionals to evaluate a patient's oxygenation status and determine a patient's need for the administration of oxygen as a medical intervention. The oxygen saturation value is reported as a percentage (Sp02) of the maximum amount of oxygen that the blood can bind. A healthy individual will have an arterial blood Sp02 level between 95%-100%. If the arterial Sp02 drops below 90 percent in a healthy adult, internal organs are at risk of not receiving sufficient oxygen to maintain life.
  • the most commonly used medical device for measuring a patient's oxyhemoglobin saturation level is a non-invasive oximetry probe placed (clamped) on an extremity of the patient; usually one of the fingers, toes, earlobes, or forehead.
  • a non-invasive oximetry probe placed (clamped) on an extremity of the patient; usually one of the fingers, toes, earlobes, or forehead.
  • Such an oximeter sends two wavelengths of light from one side of the clamp through the patient's capillary beds to the opposite side.
  • the other side of the clamp has a photo detector that reads the amount of light transmitted, which can be translated into an oxygen saturation value.
  • Such devices can produce inaccurate readings for a variety of reasons, including hypoperfusion, callused distal extremities, or the presence of an opaque layer on the finger nail such as nail polish.
  • Non-invasive oximetry probes also regularly fall off the patient thereby preventing continuous, reliable data.
  • Non-invasive probes can cause pressure ulcers on the extremities or cause minor burn marks if they are not regularly repositioned. Additionally, inaccurate pulse oximetry measurements lead to increased alarms which can lead to documented healthcare provider alarm fatigue. In cases of hypoperfusion, Sp02 readings from the extremities do not match those of central Sa02 (oxygen saturation of arterial blood) levels, as they do in healthy patients. In most cases of hypoperfusion, non-invasively calculated Sp02 is not as adequately accurate or is entirely undetectable.
  • the invention is a modular intravascular oximetry device designed to terminate within a peripheral artery, and a method for detecting blood oxygenation using such a device.
  • the modularity allows this device to be inserted into any existing arterial catheter apart from brand and could be inserted at any time, at catheter placement, after placement, and removed at any time.
  • the device sends and receives a light signal into the blood vessel via a fiber optic cable and detects the light reflected off the hemoglobin through another fiber optic cable.
  • the device then translates these light signals into blood oxygen saturation values displayed on an external monitor. This oxyhemoglobin saturation value can be used as a metric of the overall oxygenation status of a patient.
  • the invention measures arterial blood oxygenation directly instead of using capillary bed oxygenation as a proxy. This avoids any problem of variance between these two values due to
  • the invention also avoids the problem of introducing substantial additional risk of infection, as it is designed for use in conjunction with an existing arterial catheter that the patient already has inserted into a peripheral artery as part of the standard best practices in intensive care units. This limits the need for an additional invasive procedure and indwelling vascular line.
  • the device itself and the catheter into which the device is inserted are firmly securable to the patient, and thus they would not be able to casually fall off and cease oxyhemoglobin transduction as is common with standard non-invasive probes. Use of this probe in a venous catheter is considered, although current understanding of peripheral venous oxyhemoglobin saturation normal values is not known in the literature.
  • the probe can be used in analogous ways in other tubular structures and for other measurements.
  • One of the primary aims of this aspect of the invention is to allow the insertion of a modular fiber optic oximetry device into pre-existing catheter systems commonly used to measure other physiological states (i.e. blood pressure or BP) or introduce medicines or other fluids into the bloodstream.
  • Pre-existing catheter systems are ubiquitous in hospital settings and peripherally terminating arterial catheters are commonly used in intensive care units, where hypoperfusion is common.
  • the use of a modular fiber optic oximetry device in conjunction with a pre-existing catheter line is achieved via the use of a Y-luer-lock connector. Any three-port connector could be considered (e.g. Y or T connector).
  • the invention is not necessarily limited to the same.
  • the optics could pass through either Y-port channel; one channel usually should remain available for BP transducing or other functions.
  • the diameter of the fiber optic cable in such an embodiment would be sufficiently small to prevent the occlusion of flow through the connector and the rest of the catheter system thereby not preventing or unduly dampening the ability of the arterial catheter to perform other and/or concurrent functions (e.g. to transduce blood pressure readings and draw blood for lab work as for which it was initially intended).
  • the term modular is used to indicate, e.g., the device could be inserted into any existing arterial catheter apart from the catheter and could be inserted at any time; e.g. at catheter placement, after placement, etc., and removed at any time too.
  • aspects of the invention relate to use of a modular optical interrogation and feedback subsystem inside a catheter or other tubular structures for a variety of other possible uses. Examples include but are not necessarily limited to measuring a variety of arterial blood gases, direct hemoglobin measurement, and solid tissue measurements, as will be further discussed later.
  • Figure 1 shows a lateral perspective view the Y-luer-lock connector assembly 14 of a first embodiment of the invention (the Y connector is but one exemplar of a three-way connector).
  • a conventional intravascular catheter sub-assembly 22 elongated cannula portion for insertion into a blood vessel and a cup-shaped proximal connector portion to snap-in or otherwise releasably connect to a Luer taper type connector like 14
  • the arterial catheter 22 is inserted into a peripheral blood arterial vessel and terminates peripherally.
  • a proximal channel portion 18 connects the Y-luer- lock 14 out its back or proximal end to a conventional intravascular (IV) line, an arterial pressure transducing tube, or a similar tube (not pictured in Figure 1, but see, e.g., Figs.
  • a branch channel 16 (through the oblique-branch of the Y-shape of luer-lock 14) connects to distal channel portion 20 of the Y-luer-lock 14.
  • a double fiber optic cable 2 such as are commercially available and known in the art (see, e.g., U.S. Patent 8,521,248 B2, incorporated by reference; see its Figure 1 as one example) passes through the branch channel 16 and into standard luer-lock arterial catheter 22.
  • the fiber optic cable 2 may be permanently fixed to the Y-connector 14 to eliminate the ability for the fiber optic cable 2 to advance or migrate into the vessel.
  • the fiber optic module can be removably installed into the catheter for both retro-fitting existing catheters and selective use and removal.
  • the module can be temporarily positioned, secured, or placed in the catheter by any number of techniques as opposed to permanently.
  • a few non-limiting examples are adhesives, pins, clamps, or interference fit at or near the point of entry into the catheter or proximal from that.
  • the end of the branch avoid any loss of blood out of the vessel or entrainment of air into the vessel.
  • the rest of the oximetry device, the optical module (not pictured in Fig.
  • Figure 2 shows a greatly enlarged cross sectional view (taken along line "Fig. 2- Fig. 2" of Fig. 1) of an embodiment of the double fiber optic cable 2.
  • the fiber optic cable 2 connects to a light source and a photodiode (not pictured), which is in turn connected to a calculation and display apparatus (see Figure 3).
  • Figure 3 shows a reduced scale perspective view of how an exemplary
  • inventions operate with respect to the patient, and includes a broad view of related components of the functioning device.
  • the standard catheter 22 enters the patient at one end and is connected to the luer-lock 14 (pictured in more detail in Figure 1) at the other.
  • Figure 4 shows a partial cross sectional perspective view (sectioned axially) of how an exemplary embodiment of a double optical fiber cable of this system would be incorporated in a standard Y-luer-lock connector such as 14.
  • Figure 5 is a picture of a prototype of the instrument of Figure 1.
  • Figures 6 and 7 are alternative enlarged-in-scale descriptions of a cross-section like that of Figure 2.
  • Figure 8 is a graph of test results.
  • Figure 9 is a diagrammatic view of a set-up of an apparatus at least similar to
  • Figure 1 for measurement of a variety of arterial blood gases by using a multi-colored adjustable dye wheel at the light input to the fiber optic.
  • Figure 10 is a diagrammatic view related to use of an apparatus at least similar to
  • Figure 1 for measurement of a variety of blood gases by using a fiber optic coated with a variety of different fluorescent dyes.
  • Figure 11 is a diagrammatic illustration of a similar apparatus to Figure 1 with a color wheel to change color of emitted light and a photoreceptor to receive and translate the return light.
  • Figure 12 is a diagrammatic illustration of a similar apparatus to Figure 1 with multiple light sources available to inject into the fiber optic (individually or in
  • Figures 13A and B are diagrammatical illustrations of use of similar apparatus to that of Figure 1 for solid tissue insertion and measurement.
  • Figure 14 is a system diagram illustrating how an embodiment of the invention can be hooked up to an oximeter module.
  • Figures 15A and 15B are system diagrams illustrating how embodiments of the invention can be hooked up to an oximeter module or other external components.
  • Figure 16 is a system diagram illustrating how an embodiment of the invention can be hooked up to a prior art oximeter module.
  • Figures 17A and B are illustrations of one example of optical connections to an optical module (Figure 17A) and to the probe ( Figure 17B) such as can be used in the systems of Figures 14-16. Note that the probe connection should be one connecting piece with two optic strands/bundles, but are shown here separated.
  • Figure 18 is a highly diagrammatical illustration of an embodiment of the invention as inserted in a patient's blood vessel.
  • Figure 19 illustrates the fiber optic tip placed recessed back from tip of intravascular catheter or needle or tubular structure.
  • Figure 20 illustrates the fiber optic tip placed at tip of intravascular catheter or needle or tubular structure.
  • ABG arterial blood gas
  • the invention can be applied in analogous ways to other measurements. A few non-limited examples are venous measurements and solid tissue measurements.
  • oximetry For example, several embodiments will be discussed in the context of oximetry.
  • a variety of commercially-available oximetry back-end systems or units are available to which the probe module of the present invention can be operatively connected.
  • the probe module of the present invention can be combined with other components to obtain other types of measurements.
  • the probe module occupies approximately one-half the interior diameter of the catheter lumen. It is to be understood that this can vary. For example, it could be less if sufficiently small diameter but sufficiently effective fiber optics and any enclosure or binding of them are available relative the lumen inside diameter.
  • the precise way the probe module occupies interior catheter lumen space can vary.
  • the probe module could be positioned in abutment with the catheter internal wall all along the catheter. But it does not necessarily have to be in abutment. As will be discussed, so long as the probe module leaves sufficient continuous space along the catheter lumen for an effective catheter function, the amount of space the probe module occupies and how it occupies that space can vary.
  • the lumen in which the probe module is placed can vary according to need or desire. As will be appreciated, it can differ in material, form factor, physical characteristics and otherwise as between a catheter for insertion into an artery or vein versus insertion into solid tissue.
  • One embodiment of the invention includes a standard luer-lock arterial catheter 22, connected via a luer-lock to the distal end channel portion 20 of a Y-luer-lock connector (generally 14).
  • a fiber optic cable (generally 2) is threaded into the arterial catheter 22 and extends at its first or distal end just beyond, or at, the distal end of the catheter 22 that terminates in a peripheral artery in the patient 28 (see at Figure 3). Fiber optics will have standard cladding and coating as indicated by brand or size utilized per application to prevent inadvertent dissemination of emittance or receiving light signal.
  • the fiber optic cable 2 can be fixedly attached to the interior surfaces of the Y-luer-lock 14 where the fiber optic cable 2 passes through it, entering at the Y-channel or branch channel 16, and exiting at the distal end channel portion 20.
  • the proximal Y-channel portion 18 of the Y-luer-lock (generally 14) may be attached to an IV line, an arterial pressure transducing tube, or another similar tubing system (not shown but well known in the art). Even though the internal components of the fiber optic cable 2 are surrounded by a protective outer jacket 3 (Fig. 2), the outside diameter of the fiber optic cable 2 is small enough that it does not significantly block flow through channel portions 18 and 20 of the Y-luer-lock 14 in general or particularly the flow through distal channel portion 20.
  • the outer diameter or perimeter of the fiberoptic probe is not to exceed approximately one-half the inner diameter of the intravascular catheter or open channel on the y-connector.
  • the fiber optic cable 2 itself includes, inside jacket 3, a first fiber optic 4 attached at the fiber optic cable's second or proximal end, not inside the artery, to light source 10 ( Figure 3).
  • the fiber optic cable 2 also includes inside jacket 3 a second fiber optic 6 attached at the second or proximal end to a photo detector 8 ( Figure 3).
  • the photo detector 8 is electrically coupled to a processor 24 which takes the electric signal from the photo detector 8 that corresponds to the intensity of the light after passing through the patient's blood reflectance off of oxyhemoglobin, and calculates the oxygenation of the blood based on a series of natural -law-based calculations. Examples are as follows:
  • Hb02 - Oxyhemoglobin hemoglobin with oxygen molecules bound to it.
  • the processor 24 is connected to a display 26 via an electronic connector 30.
  • Processor 24, display 26, double fiber optic cable 2, and luer lock assembly 14 are commercially available. Examples are Edwards EV1000 Clinical Platform (Irvine, CA), Phillips Healthcare Pulse Oximetry Monitoring Equipment, Teleflex Arrow Arterial Catheter (20 Ga.) at Teleflex Medical 2917 Week Drive Research Triangle Park, NC 27709, Qosina Inc. Y-Connector (part 84049) at 150-Q Executive Drive, Edgewood, NY 11717-8329, TCG-MA 100H2 Fiber at OFS Fitel LLC 2000 Northeast Expressway, 30071 USA).
  • the display shows the results of the calculations as a medically relevant value for determining the blood oxygenation of the patient and whether medical intervention via oxygen therapy is appropriate to correct low arterial blood oxygenation. See, e.g., Fig. 14. See also Figure 16, which shows how a standard "Edwards" set up would be configured to work with embodiments of the invention.
  • Double optic fiber 2 has an outer diameter approximately one-half the inside diameter of lumen 23 (the inside space of the cannula of catheter 22). This leaves a substantial free space inside the cannula.
  • a cross-sectional diameter of cable 2 of about 1 ⁇ 2 of the cross-sectional diameter of the lumen of the cannula of catheter 22 results in much more free cross-sectional area of lumen 23 relative to the cross-sectional area of cable 2. This also allows for easy threading of fiber optic cable 2 through the catheter (and removal therefrom), including when catheter 22 is pre-placed in operative position in patient 28.
  • the quite small outer diameter (-300 micrometers OD) can provide the independent function of gathering oximetry information from arterial/venous blood of the patient without a second invasive procedure. It essentially shares the single lumen interior space of a conventional arterial catheter. It can be withdrawn independently of the catheter. It does not require modification of the catheter. However, some variation of relative size is possible.
  • Figures 5-7 are a photograph of a prototype (with catheter separated like Figure 1) and additional cross-sections like Figure 2.
  • Changes could include elongating the intravascular fiberoptic strands in order to be used with different types of arterial catheters such as neonatal umbilical arterial lines, the optics would need to be longer so that the tip of the optics still terminates at the tip of the catheter.
  • Embodiment 1 This relates to using an apparatus at least similar to that of Embodiment 1 in measuring a variety of arterial blood gases (ABGs).
  • ABSGs arterial blood gases
  • the method is for measuring arterial blood gas values (i.e. pH, PaC02, Pa02, bicarbonate). It can use known technologies for determining the measurements from the returned optical signal from the apparatus. For some background, see discussion of arterial blood gases below. See also, (Tintinalli's Emergency Medicine: Comprehensive Study Guide, 8e Judith E. Tintinaili, J. Stephan Stapczynski, O. John Ma, Donald M. Yealy, Garth D. Meckier, David M. Clme).
  • arterial blood gas values i.e. pH, PaC02, Pa02, bicarbonate
  • ABST arterial blood gas
  • An ABG test uses blood drawn from an artery, where the oxygen and carbon dioxide levels can be measured before they enter body tissues.
  • Partial pressure of carbon dioxide (PaC02). This measures the pressure of carbon dioxide dissolved in the blood and how well carbon dioxide is able to move out of the body.
  • the pH measures hydrogen ions (H+) in blood.
  • the pH of blood is usually between 7.35 and 7.45.
  • a pH of less than 7.0 is called acid and a pH greater than 7.0 is called basic (alkaline).
  • Bicarbonate is a chemical (buffer) that keeps the pH of blood from becoming too acidic or too basic.
  • Oxygen content (02CT) and oxygen saturation (02Sat) values.
  • 02 content measures the amount of oxygen in the blood.
  • Oxygen saturation measures how much of the hemoglobin in the red blood cells is carrying oxygen (02).
  • Blood for an ABG test is taken from an artery. Most other blood tests are done on a sample of blood taken from a vein, after the blood has already passed through the body's tissues where the oxygen is used up and carbon dioxide is produced.
  • each ABG (Arterial blood gas) metric is measured individually, stored and displayed as a set of metrics (e.g. pH, PaC02, Pa02, HC03). Each metric can be stored internally and then the set displayed together approximately every few minutes. Average measurements can be displayed to limit aberrancy in individual measurements. * See description of Optical Fluorescence Technology from Terumo at http://www.terumo-cvsxom/optimizing/2012OCT_OpticalFluorescenceTech.shtml incorporated by reference herein.
  • this relates to this probe could be used in conjunction with this existing platform in order to continually measure ABG values at the bedside without needing lab draws.
  • This probe is another method by which to use basic technology of Embodiment 1. Note, use in a venous catheter to yield Pv02, PvC02, venous pH is included.
  • this claim is stating that this probe could be used in conjunction with this existing platform in order to continually measure hemoglobin/hematocrit values without needing lab draws.
  • This probe is another method by which to use this existing technology advantageously. See, for example, Figures 11 and 12, which relate to alternative ways to introduce different light wavelengths into the emitting fiber of the dual fiber optic combination.
  • Figure 11 shows a color wheel of different sections that could be selectively moved between a starting light source and the entrance to the emitting fiber.
  • Figure 12 shows multiple light sources which could be selectively turned on (one at a time, or in any combination) to alter the light into the emitting fiber.
  • the dual-fiber probe would be inserted into a solid tissue structure such as the kidney (see “Solid tissue” diagrams of FIGURES 13A and B) through the inner lumen of a needle (FIG. 13B).
  • the needle would be used to provide support to the optics so that they do not bend or kink, a firm catheter could be used (FIG. 13A).
  • the fiberoptic tip would be at the tip of the needle/catheter, or extended slightly in front or behind the needle tip.
  • the same principal of oximetry as described in the original claims would be utilized here for direct tissue oximetry.
  • the pressure port of the Y-connector would be hooked up to a standard pressure transducer to note increase/decrease in pressure in the solid tissue indicating inflammation (increase) and possible necrosis.
  • Oximeter cross section tip diagrams e.g. FIGURES 6 and 7 are included to show the relationship between the size of the dual-optic probe and the catheter, or needle (if used in solid structure).
  • the optic outer diameter is approximately 1/2 the inner diameter of the catheter/needle. Note that bench testing confirms that there is no difference in pressure transduction with or without the oximeter probe in place; on the order of half the inner diameter of the catheter/needle should be reserved for the optics.
  • Optic tip location discrepancy o Originally the optic tip was hypothesized to be best if slightly recessed from the tip of the arterial catheter. While it was claimed that this location provided the “best” results, the term “best” was not quantified.
  • This probe tip resides flush with the tip of the arterial catheter. This will decrease the excess turbulent flow and the unwanted mixing of flush solution and blood.
  • FIG. 20 shows the arterial catheter with the probe extending to its tip. There is no area of reduced flow as compared to the systemic arterial flow as there is with the recessed tip. Therefore any concem for turbulence is greatly reduced or eliminated.
  • Displayed arterial blood gas (ABG) metrics could be calculated as averages of multiple collected values over a period of time. Note, the time period to collect a few values should be relatively short, 1-5 minutes. Individual values could be collected and stored locally, calculated into averages and displayed every certain time period. For example, 10 PaC02 values could be collected, one every 30 seconds for 5 minutes and then 1 PaC02 value is displayed every 5 minutes along with all other ABG values; one full ABG would be displayed every 5 minutes.
  • This component was added to provide oscillatory flow of fresh blood to the recessed optic tip.
  • o Proposed Solution Utilizing the dual-optic probe provides with one sending and one receiving fiber, This allows larger optics for each to be used, which potentially leads to a stronger received signal and more reliable data.
  • the peripheral intra-arterial probe could be used in conjunction with existing ABG and hemoglobin monitoring platform technology (for example, Terumo CDI 500 Blood Parameter Monitoring System).
  • ABG and hemoglobin monitoring platform technology for example, Terumo CDI 500 Blood Parameter Monitoring System.
  • This technology on a miniaturized scale to provide real-time Sa02 and Hemoglobin measurement at the bedside. Providing this real-time metric would decrease lab draws (i.e. invasive line accessing and risk for infection, venipuncture, patient discomfort), healthcare- induced anemia, and healthcare spending on repeated lab tests.
  • the minimally invasive fiber-optic probe could be inserted into a solid tissue of concern, such as the kidneys during cardiopulmonary bypass to observe for inadequate renal perfusion.
  • a solid tissue of concern such as the kidneys during cardiopulmonary bypass to observe for inadequate renal perfusion.
  • sensor spacing i.e. distance between emitting light and receiving photodiode on current transcutaneous oxygenation probes
  • the probe could be inserted through a small sheath inserted over a needle into the tissue (See: FIGURES 13A and B).
  • the probe can be inserted into an artery or vein or tissue.
  • the probe is inserted and connected as described below. It is to be understood this is one example. Variations are possible.
  • FIGURE 18 One orientation is as shown in FIGURE 18 (e.g. an angle and with distal end pointed upstream of direction of blood flow). Additionally:
  • the two optical fibers are wrapped together, one connected to an LED, one to a photoreceptor.
  • the strands or bundle are connected to a Y-connector (or other) which attaches to a hub of any arterial catheter.
  • the combination can be added or removed to any arterial catheter. The same is true for venous catheters and applications.
  • the LED and photoreceptor are outside of the body.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Optics & Photonics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Physiology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un dispositif et un procédé de mesure, entre autre, de valeurs d'oxygénation du sang, du gaz sanguin artériel/veineux, et/ou d'hémoglobine dans un cathéter artériel ou veineux déjà inséré dans un patient. L'invention permet la mesure de paramètres significatifs et généralement compris d'oxygénation du sang et de l'échange gazeux chez des patients hypo-perfusés tout en évitant un inconfort ainsi que des risques d'infection supplémentaires liés à l'insertion d'un dispositif autonome présentant son propre cathéter. Des utilisations analogues de l'appareil pour d'autres mesures sont possibles.
PCT/US2017/013199 2016-01-12 2017-01-12 Dispositif modulaire à sonde de mesure du sang intravasculaire par fibre optique périphérique et procédé associé WO2017123764A1 (fr)

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TWI695174B (zh) * 2019-04-25 2020-06-01 國立交通大學 微型化感測探針及其製造方法
US11369274B2 (en) 2017-11-10 2022-06-28 Becton, Dickinson And Company Method and device for verification of intra-luminal placement and patency for vascular access devices

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Publication number Priority date Publication date Assignee Title
US20190388635A1 (en) * 2016-11-30 2019-12-26 John Loewen Lighted bougie

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US3941121A (en) * 1974-12-20 1976-03-02 The University Of Cincinnati Focusing fiber-optic needle endoscope
US5673694A (en) * 1995-08-08 1997-10-07 Henry Ford Health System Method and apparatus for continuous measurement of central venous oxygen saturation
US20030195577A1 (en) * 2001-10-23 2003-10-16 Pigott John D. Steerable catheter and method for locating coronary sinus
US20100030042A1 (en) * 2005-05-04 2010-02-04 Denninghoff Kurt R Method and device for determining oxygen saturation of hemoglobin, for determining hematocrit of blood, and/or for detecting macular degeneration
US20100094126A1 (en) * 2005-09-13 2010-04-15 Children's Medical Center Corporation Light-guided transluminal catheter
US20110118577A1 (en) * 2007-07-31 2011-05-19 Up Management Gmbh Catheter system having an optical probe and method for the application of an optical probe in a catheter system

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CA971768A (en) * 1972-02-01 1975-07-29 Robert F. Shaw Oximeter and method
US5284138A (en) * 1991-07-09 1994-02-08 C. R. Bard, Inc. Apparatus and method for positioning a sensor away from the blood vessel wall
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Publication number Priority date Publication date Assignee Title
US3941121A (en) * 1974-12-20 1976-03-02 The University Of Cincinnati Focusing fiber-optic needle endoscope
US5673694A (en) * 1995-08-08 1997-10-07 Henry Ford Health System Method and apparatus for continuous measurement of central venous oxygen saturation
US20030195577A1 (en) * 2001-10-23 2003-10-16 Pigott John D. Steerable catheter and method for locating coronary sinus
US20100030042A1 (en) * 2005-05-04 2010-02-04 Denninghoff Kurt R Method and device for determining oxygen saturation of hemoglobin, for determining hematocrit of blood, and/or for detecting macular degeneration
US20100094126A1 (en) * 2005-09-13 2010-04-15 Children's Medical Center Corporation Light-guided transluminal catheter
US20110118577A1 (en) * 2007-07-31 2011-05-19 Up Management Gmbh Catheter system having an optical probe and method for the application of an optical probe in a catheter system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11369274B2 (en) 2017-11-10 2022-06-28 Becton, Dickinson And Company Method and device for verification of intra-luminal placement and patency for vascular access devices
TWI695174B (zh) * 2019-04-25 2020-06-01 國立交通大學 微型化感測探針及其製造方法

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US20170196486A1 (en) 2017-07-13

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